Global Lead Statistical Programmer

Grade : Manager

Location : Hybrid at Gurugram / Mumbai. 100% Remote for the right candidate.

Job Purpose

Lead one or more Phase I-IV studies programming activities as per the project strategies.

Work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc / post hoc analysis.

Work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in a timely manner with high quality.

Participate in and contribute to development of standard macros, libraries, processes and act as a team player on the various programming tasks.

Key Roles and Responsibilities

Lead statistical programming

activities for a therapeutic area or compound / indication within multiple studies / projects in various study activities to ensure timely and high-quality programming deliverables in assigned projects and areas.

Develop and maintain programming documentations following programming standards and processes. Create

CDISC standard SDTM mapping specifications

and

ADaM specifications.

Develop and oversee the development of SAS programs

for the

creation of SDTM and ADaM datasets following CDISC standards

and reports (Tables, Listings and Figures).

Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.

Participate in the CRF annotation, review of SAP, TLFs specifications development and TLFs review.

Handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for the regulatory submission to FDA / EMA / PMDA or other agencies.

Support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.

Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.

Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.

Performing end-to-end programming activities, act as a team player and SME.

Focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.

Ensure all work is completed adhering to the internal SOPs where applicable.

Mentor and Coach new hires and junior programmers. Require good collaborative skills.

Qualification, Skill and Competencies Requirements

Minimum Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience

in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.

Oncology Therapeutic area preferred.

Strong SAS programming skills

in a clinical data environment with excellent analytical skills. Working knowledge of other

programming languages such as R, Python etc. is a plus.

Great knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).

Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Prior PTL experience, attention to detail and able to adapt to a fast-paced environment.

Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset.

Problem solving and innovative skills that demonstrate initiative and motivation.

Demonstrated and applied SAS programming skills. SAS certificates a plus.